Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062746
Company: CARNEGIE
Company: CARNEGIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN | ERYTHROMYCIN | 250MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/22/1986 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/10/2022 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/10/2022 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2009 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/06/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/20/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
ERYTHROMYCIN
CAPSULE, DELAYED REL PELLETS;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ERYC | ERYTHROMYCIN | 250MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | Yes | AB | 050536 | DR REDDYS LABS SA |
| ERYTHROMYCIN | ERYTHROMYCIN | 250MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 062746 | CARNEGIE |